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Completed

NCT Number: NCT04997447

Enforced Reduction in Physical Activity and Recovery in Older Adults

Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. All subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. Half of the recruited subjects (n=40) will be randomized into the intervention group and half (n=40) randomized into the control group. The intervention group is then required to reduce their daily steps to <2000 for a 2-week period. Thereafter, the intervention group participates to a 4-week strength+endurance training rehabilitation program and no longer has restricted daily step count. The control group continues their normal habitual physical activity level throughout the 6-week study period.

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Key information

Conditions

Muscle Degeneration Body Weight Body Weight Changes Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms Walking, Difficulty

Age range

70 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jyväskylä

Jyväskylä, Central Finland, 40014, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 70-80 years,
  • community-dwelling,
  • able to walk 500 m without assistance or use of walking aid and regularly walking >5000 steps per day,
  • MMSE >24,
  • BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
  • no serious cardiovascular or musculoskeletal disease,
  • no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),
  • non-smoker,
  • provision of informed consent.

Exclusion criteria

  • Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,
  • unwilling/unable to track daily step counts using accelerometer,
  • excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)
  • difficulty in communication due to severe vision or hearing problems
  • unwilling to provide consent or accept randomization into either study group

Treatment and study plan

Step-reduction/Exercise Rehab

Behavioral

2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults

Primary outcomes

  1. Lean leg mass

    Time frame: 6 weeks

    DXA-measured total lean mass of the legs

Secondary outcomes

  1. Whole-body fat mass

    Time frame: 6 weeks

    DXA-measured total body fat mass

  2. Maximum isometric leg extension force

    Time frame: 6 weeks

    Maximum strength of legs

  3. Walking economy

    Time frame: 6 weeks

    Oxygen uptake while walking at 3 and 5 km.h-1

  4. Short Physical Performance Battery (SPPB)

    Time frame: 6 weeks

    Walking, balance and chair-rise tests

  5. Blood pressure

    Time frame: 6 weeks

    Systolic and diastolic blood pressure during rest (sitting)

  6. HOMA indices

    Time frame: 6 weeks

    Blood glucose and insulin concentration based calculations related to insulin resistance and beta-cell function

  7. White blood cell respiration

    Time frame: 6 weeks

    Isolated white blood cell respiration as a marker for mitochondrial function

Sponsors and collaborators

Lead sponsor

University of Jyvaskyla

Other

Collaborators

  • University of Eastern Finland

Registry information

Acronym: ENDURE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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